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Previous studies in both the cardiovascular and orthopedic study have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate largely without major complications . In addition, many meta-analyses have confirmed these results . However, there is little information about comparison among the different routes of TXA administration in TKA. Therefore, this study has been designed to determine which administration route of TXA is more effective and safety.
Objectives:To assess the efficacy and safety between the two different applying routes.
Patients in this project will be randomly divided into three groups , one group is a blank group and the rest two receive either the topical or the intravenous form of tranexamic acid during unilateral TKA(total knee arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction events will be recorded to assess the safety of the tranexamic acid during a six-week follow-up for each patient.
All surgery are under general anesthesia, through direct lateral approach with cementless prosthesis.For all patients, the drain tube will be clamped and closed completely for 2 hours; then the clamp will be fully opened.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 | Placebo Comparator | 60 Milliliters（ml）Normal saline (0.9% sodium chloride) will be applied by soaking the knee cavity for at least 3 minutes before wound closure and then sucked away. |
|
| Group2 | Experimental | two-dose intravenous tranexamic acid will be applied as follow: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline (0.9% sodium chloride),the first dose 15' before the tourniquet deflation and the second dose at 180' after the first dosage |
|
| Group 3 | Experimental | 3g Tranexamic Acid diluted to 60 Milliliters（ml） with normal saline (0.9% sodium chloride) will be applied by soaking the knee cavity for at least 3 minutes before wound closure and then sucked away. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normal saline | Drug | The normal saline solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Blood Loss（TBL） | Total Blood Loss（TBL） was calculated with equations described by Gross et al. | calculated by an equation at the fifth postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Transfusion rates | Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, over the course of the patient's hospital stay | from the day of surgery to the day of discharge,an expected average of 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary | Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism | twelve weeks after surgery |
| other thromboembolic event |
Inclusion Criteria:
Exclusion Criteria:
9.History of thromboembolic disease
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| Name | Affiliation | Role |
|---|---|---|
| jianmin feng, master | ruijin hospital，shanghai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Department of Ruijin hospital | Shanghai | Shanghai Municipality | 200001 | China |
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| ID | Term |
|---|---|
| D058734 | Exsanguination |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
|
| Tranexamic Acid | Drug | The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet. |
|
|
| Tranexamic Acid | Drug | The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the circuit nurse and the circuit nurse will ask the anesthetist to apply the solution intravenously before tourniquet deflation. The dosage and applying route can also be looked up in doctor's order sheet. |
|
|
Clinically proven Acute Myocardial Infarction、acute kidney infarction or cerebral infarction
| twelve weeks after surgery |
| drainage output | it will be recorded at the first day and the second day after surgery |
| human serum albumin usage | the investigators will record the dosage of the human blood albumin used in each patient. | from the day of surgery to the day of discharge,an expected average of 7 days |
| American Society of Anesthesiologists Physical Status Classification (ASA class) | at the day of surgery |
| Disseminated Intravascular Coagulation（DIC） | at any day before surgery and the first the fifth day after surgery |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |